NCT07677319 SAGE-Heart : Senior Assessment fraGility and Post-opErative QALYs 1 Year After Emergency HEART Surgery for Patients Aged 75 and Older
| NCT ID | NCT07677319 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Frailty |
| Study Type | INTERVENTIONAL |
| Enrollment | 265 participants |
| Start Date | 2025-12-03 |
| Primary Completion | 2028-12-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 265 participants in total. It began in 2025-12-03 with a primary completion date of 2028-12-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The hypothesis is that the preoperative Clinical Frailty Score (CFS) is a predictive factor for a loss in quality-adjusted life years (QALYs) one year after emergency cardiac surgery under cardiopulmonary bypass (CPB) in patients aged 75 years and older.
Eligibility Criteria
Inclusion Criteria: * Patients aged ≥ 75 years who are affiliated with or beneficiaries of a social security scheme and undergoing emergency cardiac surgery under cardiopulmonary bypass, either immediate or urgent (relative) : * Immediate emergency surgery: intervention performed before the start of the next working day following the decision to operate, * Urgent (relative) emergency surgery: patients not admitted electively for surgery but requiring an intervention during the current hospital stay for medical reasons, and who cannot be discharged without undergoing a definitive procedure Exclusion Criteria: * Patients requiring preoperative cardiopulmonary resuscitation * Scheduled (elective) surgery * Lack of informed consent * Impaired consciousness at the time of inclusion (defined by a Glasgow Coma Scale score \< 15) * Individuals under legal guardianship or judicial protection * Individuals participating in another interventional research protocol
Contact & Investigator
Simon CARRE, MD
PRINCIPAL INVESTIGATOR
University Hospital, Bordeaux
Frequently Asked Questions
Who can join the NCT07677319 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, studying Frailty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07677319 currently recruiting?
Yes, NCT07677319 is actively recruiting participants. Contact the research team at simon.carre@chu-bordeaux.fr for enrollment information.
Where is the NCT07677319 trial being conducted?
This trial is being conducted at Bordeaux, France.
Who is sponsoring the NCT07677319 clinical trial?
NCT07677319 is sponsored by University Hospital, Bordeaux. The principal investigator is Simon CARRE, MD at University Hospital, Bordeaux. The trial plans to enroll 265 participants.